Hydrocodone/acetaminophen 5-325 Tb

Hydrocodone is a semisynthetic opioid analgesic that acts as an agonist at mu-opioid receptors in the central nervous system (CNS), producing analgesia, sedation, and respiratory depression. Acetaminophen is a non-opioid analgesic and antipyretic, believed to act primarily through central inhibition of prostaglandin synthesis (COX-3 inhibition) and possibly through modulation of the serotonergic descending pain pathways.

Urgent Side Effects: Seek Medical Help Immediately

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or passing out
Clammy skin
Excessive sweating
Confusion
Trouble walking
Severe constipation or stomach pain, which may indicate a severe bowel problem
Hearing loss or changes in hearing
Chest pain or pressure
Abnormal heartbeat (fast or slow)
Breathing difficulties, including:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Mood changes
Trouble urinating
Changes in urination patterns
Vision changes
Seizures
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other severe skin reactions, which can be life-threatening
Signs of serotonin syndrome, a potentially life-threatening condition, including:
+ Agitation
+ Balance problems
+ Confusion
+ Hallucinations
+ Fever
+ Abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea
+ Upset stomach or vomiting
+ Severe headache

Other Possible Side Effects

Most people taking this medication do not experience severe side effects. However, some may encounter mild or moderate side effects, including:

Constipation
Upset stomach or vomiting
Stomach pain or heartburn
Dizziness
Drowsiness
Fatigue
Headache

If you experience any of these side effects or any other unusual symptoms, contact your doctor for advice. They can help you manage your symptoms and determine the best course of action.

Reporting Side Effects

If you have questions or concerns about side effects, you can:

Contact your doctor for medical advice
Report side effects to the FDA at 1-800-332-1088
Submit a report online at https://www.fda.gov/medwatch

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel blockage or narrowing
Other medications you are currently taking, particularly:
+ Buprenorphine
+ Butorphanol
+ Linezolid
+ Methylene blue
+ Nalbuphine
+ Pentazocine
If you have taken any medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking this medication with these drugs can lead to very high blood pressure)

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without consulting your doctor first.

Important Warnings and Cautions

Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Avoid driving and performing tasks that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position and exercise caution when climbing stairs.

Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be required to achieve the same effect. If you experience a decrease in the medication's effectiveness, consult your doctor. Do not exceed the prescribed dose.

Additionally, regular use of opioid medications like this one can cause dependence. If you need to reduce the dose or stop taking this medication, consult your doctor first, as sudden changes may increase the risk of withdrawal or other severe problems. Follow your doctor's instructions carefully and report any adverse effects, such as increased pain, mood changes, suicidal thoughts, or other concerns.

Interactions with Other Substances
Do not consume alcohol or products containing alcohol while taking this medication, as this can lead to unsafe and potentially fatal interactions.

Acetaminophen Precautions
Avoid taking other products that contain acetaminophen, and carefully check the labels of all medications. Exceeding the recommended daily dose of acetaminophen can cause liver damage. Follow the dosage instructions exactly, and do not take more than 4,000 mg (milligrams) of acetaminophen per day unless directed by your doctor. Certain individuals, such as those with liver problems or children, may require lower doses. If you are unsure about the safe dose for you, consult your doctor or pharmacist. If you suspect you have taken too much acetaminophen, contact your doctor immediately, even if you feel well.

Liver Problem Warning Signs
Monitor for signs of liver problems, such as dark urine, fatigue, decreased appetite, nausea, stomach pain, pale stools, vomiting, or yellowing of the skin and eyes. If you experience any of these symptoms, contact your doctor promptly.

Hormonal and Adrenal Gland Effects
Long-term use of opioid medications like this one can lead to decreased sex hormone levels. If you experience a decrease in libido, fertility problems, irregular menstrual periods, or ejaculation difficulties, consult your doctor.

Additionally, taking an opioid medication like this one can cause a rare but severe adrenal gland problem. If you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite, contact your doctor immediately.

Seizure Risk
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Discuss your risk with your doctor.

Age-Related Precautions
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Breastfeeding Precautions
If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and harm your baby. Seek medical attention immediately if your baby appears excessively sleepy, limp, or has breathing difficulties.

• Monoamine Oxidase Inhibitors (MAOIs) within 14 days (risk of serotonin syndrome, respiratory depression, coma, death)
• Severe respiratory depression
• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
• Known or suspected paralytic ileus
• Hypersensitivity to hydrocodone, acetaminophen, or any component of the formulation

• Other CNS depressants (e.g., benzodiazepines, other opioids, alcohol, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants): Additive CNS depression, respiratory depression, hypotension, profound sedation, coma, death.
• CYP3A4 inhibitors (e.g., macrolide antibiotics, azole antifungals, protease inhibitors): Increased hydrocodone plasma concentrations, leading to increased opioid effects and potential for fatal respiratory depression.
• CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, bupropion): Decreased conversion of hydrocodone to hydromorphone, potentially reducing analgesic effect.
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol, fentanyl, linezolid, St. John's Wort): Risk of serotonin syndrome.
• Anticholinergic drugs (e.g., atropine, scopolamine, antihistamines): Increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
• Mixed agonist/antagonist and partial agonist opioids (e.g., pentazocine, nalbuphine, butorphanol, buprenorphine): May precipitate opioid withdrawal symptoms or reduce analgesic effect.

• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): Decreased hydrocodone plasma concentrations, potentially reducing analgesic effect and leading to withdrawal symptoms in opioid-dependent patients.
• Diuretics: Opioids may reduce the efficacy of diuretics by causing the release of antidiuretic hormone.
• Antihypertensives: Opioids may cause orthostatic hypotension, additive effect with antihypertensives.
• Warfarin: Acetaminophen may potentiate the anticoagulant effect of warfarin with chronic high doses, increasing bleeding risk.

• Not available

• Excessive sedation
• Difficulty breathing or shallow breathing
• Confusion or disorientation
• Dizziness or lightheadedness
• Severe constipation
• Nausea and vomiting
• Abdominal pain
• Yellowing of skin or eyes (jaundice)
• Dark urine
• Unusual tiredness or weakness

Category C. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which can be life-threatening if not recognized and treated. Use only if the potential benefit justifies the potential risk to the fetus.

Hydrocodone and its active metabolite hydromorphone are present in breast milk. Acetaminophen is also excreted in breast milk. Risk of serious adverse reactions in breastfed infants, including sedation, respiratory depression, and death. Not recommended for breastfeeding mothers. If use is unavoidable, monitor infant closely for signs of sedation, difficulty feeding, and breathing problems. Consider pumping and discarding milk or using an alternative analgesic.

Not recommended for children under 6 years of age due to the risk of fatal respiratory depression. Use in older children should be with extreme caution, individualized dosing, and close monitoring due to variability in CYP2D6 metabolism and increased sensitivity to opioids. Acetaminophen dosing in children must be carefully calculated by weight.

Elderly patients may be more sensitive to the analgesic and adverse effects of opioids, including respiratory depression, sedation, and constipation. Start with lower doses and titrate slowly. Monitor renal and hepatic function closely.

• Always verify the acetaminophen content to ensure the total daily dose does not exceed 4000 mg (or 3000 mg in some guidelines/patients with liver risk) from all sources.
• Educate patients on the risks of addiction, abuse, and misuse, and the importance of safe storage and disposal.
• Warn patients about the dangers of combining this medication with alcohol or other CNS depressants.
• Monitor for signs of respiratory depression, especially during initiation or dose escalation, and ensure naloxone availability if appropriate.
• Counsel patients on strategies to manage opioid-induced constipation.
• Be aware of potential drug interactions, especially with CYP3A4 inhibitors/inducers and serotonergic drugs.
• Consider the patient's pain type and duration; this combination is best suited for acute, moderate to moderately severe pain where non-opioid options are insufficient.

• NSAIDs (e.g., ibuprofen, naproxen)
• Acetaminophen (single agent)
• Other non-opioid analgesics (e.g., gabapentin, pregabalin for neuropathic pain)
• Topical analgesics
• Physical therapy
• Interventional pain procedures
• Other opioid analgesics (e.g., morphine, hydromorphone, oxycodone, tramadol) as single agents, if appropriate.

If your symptoms or health problems do not improve or worsen, contact your doctor immediately. It is essential to use your medication responsibly: do not share it with others, and never take someone else's medication.

This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. Read this guide carefully when you first receive your medication, and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, consult your doctor, pharmacist, or other healthcare provider.

In the event of an overdose, a medication called naloxone can be administered to help counteract the effects. Discuss obtaining and using naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide information about the overdose, including the substance taken, the amount, and the time it occurred.

In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. When seeking help, be prepared to provide detailed information about the overdose, including what was taken, the quantity, and the time of the incident.